In short
MK-3508 is an investigational substance being studied for respiratory syncytial virus (RSV) infection. A completed Phase 1 trial enrolled 32 healthy adult male participants to assess the safety, tolerability, and pharmacokinetics of single oral doses. The trial measured how the body processes MK-3508 by tracking its concentration in the blood over time.
Key points
- MK-3508 is an investigational antiviral substance studied for respiratory syncytial virus (RSV) infection.
- The only registered trial is a Phase 1 single ascending dose study in 32 healthy adult male participants.
- The trial is completed and was designed primarily to assess safety, tolerability, and pharmacokinetics.
- MK-3508 was given as a 200 mg oral dose in this trial.
- Key measurements included maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
What is MK-3508?
MK-3508 is an investigational substance with no marketing authorisation in the registry records provided. The substance data places it in the therapeutic area of virus diseases, specifically being studied in the context of respiratory syncytial virus infection. Based on the supplementary source, MK-3508 is described as a small molecule with an undefined mechanism of action, classified as a new molecular entity. No trade names or other development codes are listed for this substance in the available data.
How does MK-3508 work?
The mechanism of action of MK-3508 is currently undefined according to the supplementary source. As a small molecule, it is a chemically synthesised substance, but the specific molecular target or pathway it affects has not been described in the available information.
Which conditions is it studied for?
- Respiratory syncytial virus infection — a common respiratory virus that can cause serious illness, particularly in infants and older adults. The Phase 1 trial investigated MK-3508 in healthy participants to understand how the drug behaves in the body before testing it in patients with RSV infection.
How is MK-3508 given?
In the registered trial, MK-3508 was administered orally as a 200 mg dose. The pharmaceutical form used in the trial is not detailed beyond the oral route of administration.
What do the clinical trials show?
One clinical trial of MK-3508 is registered. It is a Phase 1, single ascending dose study that enrolled 32 healthy adult male participants and has been completed. The trial was designed to assess the safety and tolerability of single oral doses of MK-3508, as well as to measure its plasma pharmacokinetics — that is, how the drug is absorbed, distributed, metabolised, and eliminated by the body.
The primary outcomes measured in this trial included the percentage of participants experiencing at least one adverse event, the percentage discontinuing due to adverse events, and several pharmacokinetic parameters. These parameters included the maximum plasma concentration of MK-3508 (Cmax), the time to reach that maximum concentration (Tmax), the area under the plasma concentration-time curve from dosing to infinity (AUC0-inf) and to 24 hours postdose (AUC0-24), the plasma concentration at 24 hours postdose (C24), and the apparent plasma terminal half-life (t½).
Participants in this study were healthy adult male participants. The trial was interventional, meaning participants received the study drug. The comparison arm included a placebo formulation, Ora Blend SF, used to compare against the active treatment.
What side effects are known?
The available supplementary source does not provide information on specific side effects of MK-3508. The clinical trial measured the percentage of participants with at least one adverse event as a primary outcome, but the results of these measurements are not available in the registry data.